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SPINAL FRACTURES OUR TREATMENT GUIDE 7

Spinal fractures are common around the world and can have a major impact on your quality of life. 12 Thoracic If not treated soon enough, they can even make carrying out daily tasks vertebrae impossible. Back pain, loss of appetite and sleep or respiratory problems are just a few examples. If you have been diagnosed with a , a minimally invasive treatment is a therapeutic option which may be considered. This brochure explains the different causes, consequences and current treatments for spinal fractures. If you have any questions, don’t hesitate to discuss them with your doctor. THE SPINAL

COLUMN Lumbar5 vertebrae IS MADE UP OF 33 VERTEBRAE

5Sacral The vertebrae are linked together by vertebrae and muscles that control the spinal column’s degree of flexibility. The vertebrae are separated from one another by a cartilaginous disc, which acts as a shock absorber 4 Coccygeal and protects them. They may be separated (cervical, vertebrae CONTENTS thoracic and ), or fused together P4 WHY DO THEY HAVE TO BE TREATED? P8 TREATMENT OPTIONS (as is the case at the and coccyx). P10 THE TREATMENT OFFERED TO YOU P12 AFTER THE PROCEDURE

3 WHAT’S THE PROBLEM? A spinal fracture occurs when a vertebral body collapses. Spinal fractures tend to be very painful and, if left untreated, can adversely affect your general health and well-being, hence the importance of an early diagnosis to ensure more effective management.

SPINAL FRACTURES

WHY DO VERTEBRAL COMPRESSION = THEY HAVE FRACTURE A spinal fracture can occur after an accident. Traumas can be divided into two types: TO BE • Low-energy trauma: some diseases, such as (loss of mass) or cancer (malignant tumours, metastases), combined with a low-energy trauma, such as lifting an object or turning over in bed, can cause what are known TREATED? as “fragility fractures” of the vertebrae. • High-energy trauma: road traffic accident, fall, sports and occupational accidents. 1 New Spinal Fracture Spinal fractures are very common. every 22 seconds worldwide! 1 Worldwide, in the year 2000 there were an estimated 1.4 million osteoporotic vertebral fractures3.

Spinal fractures are the most common osteoporotic fractures (46%), well ahead of fractures of the fracture (16%) and wrist (16%)2. It is estimated that, after the age of 50, almost 1 in 2 women and 1 in 5 men will suffer from an osteoporotic spinal fracture4.

5 WHAT ARE THE CONSEQUENCES? VERTEBRAL FRACTURES DIAGNOSIS In addition to being extremely painful, a spinal fracture can affect your Spinal fractures are often confused with other types of back pain. and therefore increase the risk of new spinal fractures. Therefore, report any new or unusual back pain to your doctor promptly. Early diagnosis can lead to more treatment options.

After an initial fracture RISK OF NEW ONLY 1 IN 3 FRACTURES x5 FRACTURE 5 is clinically reported 16 Each additional spinal fracture exacerbates the deformity of the spinal column6,7 (forward curvature of the spine), with an increased risk of the complications or reduced A physical exam, together with an x-ray, can help determine functional capacities indicated below: whether you have a spinal fracture. • Reduced mobility, loss of balance Physical Exam and increased risk of falls8,9 Spinal fractures may be asymptomatic, but certain signs • Reduction in lung capacity10,11 may alert your doctor: • • Chronic back pain and fatigue12,13 Sudden severe or chronic back pain • • Reduced appetite and sleeping problems10,14 Curve in the shape of your spine • • Depression, anxiety and low self-esteem. Loss of height

X-Ray Exam 20% of women who have already After a physical exam, imaging tests such as x-rays or magnetic resonance imaging (MRI) might be ordered to confirm the diagnosis suffered a spinal fracture will suffer of a spinal fracture. another one within 12 months!1

6 7 CONSERVATIVE TREATMENTS Traditional treatment for spinal fractures may include several weeks of bed rest, painkillers, physiotherapy and, sometimes, wearing a corset. Their limits • Doesn’t treat the fractured , prolonged bed rest (4 to 6 weeks) is essential for good results but diffi cult to stick to. • Morbidity associated with prolonged bed rest (, muscle atrophy, bed sores, respiratory problems)

MINIMALLY INVASIVE TREATMENTS VERTEBROPLASTY The aim of this technique is to stabilise the fracture and relieve pain. The fractured SPINAL FRACTURES vertebrae are stabilised by injecting bone cement into the centre of the vertebra. KYPHOPLASTY USING BALLOONS OR STENTS The objective of this technique is to relieve pain, stabilise TREATMENT the fracture and restore the height of the vertebral body17. The procedure involves inserting two infl atable bone tamps or two stents into the vertebra in order to create a cavity, which is OPTIONS then fi lled with bone cement. Their limits • These techniques are effective in terms of restoring independence and pain relief, but are less effective in terms of restoring vertebral height.18/19

SURGICAL TREATMENTS Traditionally, a surgical technique known as is used to treat complex spinal fractures with neurological disorders. It is used to permanently block one or more intervertebral articulations in the . Metal screws, plates or rods are used to fuse together two or more adjacent vertebrae. The aim is to stabilise the vertebral column and relieve pain. Limits and disadvantages • Major surgery, therefore a long recovery time. • Rehabilitation necessary. • Use of heavy analgesics. • Higher inter-operatively complications rate20.

9 MINIMALLY INVASIVE RESTORATION WITH SPINEJACK® The procedure is a minimally invasive surgical procedure designed to relieve pain, stabilise the fracture and restore your fractured vertebra to its initial shape. It can be done in a radiology room or operating room, in accordance with very strict cleanliness and safety standards. Under x-ray guidance, the surgeon makes two very thin incisions about one centimetre long, in your back and creates a narrow access path to the fractured vertebra in order to insert two implants. The surgeon then inserts the implants and injects bone cement to stabilise the fracture. The procedure is usually performed under general anaesthesia but may also be performed under local anaesthesia, depending on your surgeon’s recommendation. SPINAL FRACTURES This procedure takes about 30 minutes per fracture level treated, plus the preparation and recovery time. THE FRACTURED VERTEBRA INSERTION TREATMENT

OFFERED IMPLANT INSERTION INJECTION OF CEMENT TO YOU

THE RISKS OF ANY SURGICAL PROCEDURE Although the complication rate with this minimally invasive treatment has been demonstrated to be low, as with most surgical procedures there are risks associated with the procedure including heart attack, embolism, infection. Please note, however, that this procedure is not for everyone. Please consult your doctor for a full discussion of risks and whether this procedure is right for you.

11 IMMEDIATE PAIN RELIEF Patients usually report immediate relief from back pain. But as everyone perceives pain differently, a mild painkiller may be prescribed for several days.

ALMOST IMMEDIATE RETURN HOME Patients are typically discharged from the hospital 3 days after the procedure.

FAST RETURN TO WORK AND DAILY ACTIVITIES Once discharged from the hospital, you may be surprised by how quickly you’re able to resume your favorite activities.

SPINAL FRACTURES FOLLOW-UP Your doctor will probably schedule a follow up visit during which he’ll give AFTER THE you instructions specific to your overall health and level of conditioning. Please note, that the success of the treatment vary from PROCEDURE one patient to another. PATIENT TESTIMONY Bruno N., 36 years old (Mountain Rescue Professional)

I had a SpineJack® operation in January 2014 after a 17-metre fall during the final phase of a mountain rescue operation. I had a fracture of the L1 vertebra. The operation was carried out by Dr. Vouaillat at the Clinique des Cèdres in Grenoble. I was quickly back at work and enjoying my professional and sports activities, after obtaining my certificate of aptitude. Today, I can carry a 15 kg backpack, go skiing and rock climbing without any restriction.”

13 1 Int’l Osteoporosis Foundation (www.osteofound.org) 2 J Bone Miner Res, 11(7), pp. 1010-8, jul 1996 3 Osteoporos Int. 2006 Dec;17(12):1726-33. Epub 2006 Sep 16. 4 Kanis JA, Johnell O, Oden A, et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int 2000; 11:669-74 5 Ross PD, Davis JW, Epstein RS, Wasnich RD (1991) Preexisting fractures and bone mass predict vertebral fracture incidence in women. Ann Intern Med 114:919-923.v 6 Lindsay, R., S. Pack, and Z. Li, Longitudinal progression of fracture prevalence through a population of postmenopausal women with osteoporosis. Osteoporos Int, 2005. 16(3): p. 306 7 Black, D.M., et al., Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res, 1999. 14(5): p. 821-8. 8 Sinaki M. Falls, fractures, and hip pads. Curr Osteoporos Rep 2004;2(4):131-7. 9 Sinaki M, Brey RH, Hughes CA, Larson DR, Kaufman KR. Balance disorder and increased risk of falls in osteoporosis and kyphosis: significance of kyphotic posture and muscle strength. Osteoporos Int 2005;16(8):1004-10. 10 Schlaich, C., et al., Reduced pulmonary function in patients with spinal osteoporotic fractures. Osteoporos Int, 1998. 8(3): p. 261-7. 11 Leech JA, Dulberg C, Kellie S, Pattee L, Gay J. Relationship of lung function to severity of osteoporosis in women. Am Rev Respir Dis 1990;141(1):68-71. 12 Nevitt MC, Ettinger B, Black DM, et al. The association of REFERENCES radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med 1998;128(10):793-800. 13 Gold DT, Silverman SL. The downward spiral of vertebral osteoporosis: consequences (Monograph). Cedars-Sinai Medical Center 2003. 14 Pluijm SM, Tromp AM, Smit JH, Deeg DJ, Lips P. Consequences of vertebral deformities in older men and women. J Bone Miner Res 2000;15(8):1564-72. 15 Silverman SL. The clinical consequences of vertebral compression fracture. Bone 1992;13 Suppl2:S27-31 16 Garfin, S.R., R.A. Buckley, and J. Ledlie, Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine, 2006. 31(19): p. 2213-20. 17 Werner CM et al. Vertebral body stenting versus kyphoplasty for treatment of osteoporotic vertebral compression fractures: a randomized trial. J Bone Joint Surg Am. 2013 Apr 3;95(7):577-84. 18 Hulme PA et al. Vertebroplasty and Kyphoplasty: A Systematic Review of 69 Clinical Studies. Spine (2006) 31(17): 1983-200. 19 Reinhold M et al. Operative treatment of 733 patients with acute thoracolumbar spinal injuries: comprehensive results from the second, prospective, internet-based multicenter study of the Spine Study Group of the German Association of Trauma Surgery. Eur Spine J (2010) 19:1657–1676.

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